Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Inclusion Criteria:

• Age: 18-75
• ECOG score: 0 or 1
• Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
• histologically proven adenocarcinoma
• Received chemotherapy based on platinum and fluorouracil within 12 months
• Patients not previously treated with paclitaxel or irinotecan
• Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)
• Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min
• Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
• Expected survival ≥ 3 months
• Sign the informed consent form

Exclusion Criteria:

• Patients who have received irinotecan or paclitaxel chemotherapy in the past
• ECOG PS score:>2
• Advanced gastric cancer patients with extensive and severe peritoneal metastasis
• Patients with severe liver and kidney insufficiency or cardiac insufficiency
• HIV positive, active hepatitis B or C, active pulmonary tuberculosis
• Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
• Patients known to be allergic to any of the study drugs
• Pregnant or lactating female patients